FDA Approves Another Weight Loss Drug

[Anonymous]

and here is why it won't matter...

Cleary you have no idea of the bariatric market. I launched Redux and sold pondimin at Wyeth and as well as sold branded Phentermine prior to going to Wyeth. First off, payers will not cover Lorcaserin just like they didn’t cover Redux, Phentermine, or pondimin. We are in a horrible economy so the likelihood of people shelling out the money for this drug out of pocket is low. Add to that in the US, oddly enough, obesity is associated with lower socioeconomic status meaning the fat poor people who need this drug won’t have the cash to pay for it. Also there will be a huge negative public perception to overcome with prescription weight loss drugs after the Fen-Phen and Redux health debacle and associated lawsuits. Look at Xenical, it’s not like it’s setting the world on fire nor did Merdia before it got pulled. You will not see the pop up weight loss clinics in every strip mall like you did during the fen-phen era of the 1990’s which was the driving factor of the short term financial success of those drugs. After all the lawsuits most MD’s will stay very far away from this drug and will be relegated to bariatric centers versus everyone with a medical license writing for it like in the 90’s thus the market volume will be substantially lower than the last time around. Eisai is a primary care company but it is highly unlikely that PC and IM’s will play with the weight loss drugs again at a high level. At the end of the day Lorcaserin is really just a Serotonin agonist, to the way Pondimin and Redux woked and very similar to the plethora of SSRI’s on the market that payers will pay for.

Whether it gets approve or not is irrelevant because as Eisai did with oncology, they are entering a market and therapeutic area they know nothing about nor have any expertise in. Once again Eisai is making flawed assumptions on the market potential and we all see how that has worked out in oncology. Shocker I know!

http://seekingalpha.com/article/427881-arena-pharma-s-5-year-revenue-forecast



Read this and suck it!

 

[Anonymous]

http://seekingalpha.com/article/427881-arena-pharma-s-5-year-revenue-forecast



Read this and suck it!

Seeking Alpha? Really? What, was pharmalot not covering it??? Too funny yup you sum up the ignorance required to work at Eisai!

 

[Anonymous]

Look at Janet Woodcock's comments about obesity drugs this week. It's toast or delayed at least 2 - 3 years.

 

[Anonymous]

http://seekingalpha.com/article/427881-arena-pharma-s-5-year-revenue-forecast



Read this and suck it!

Stock pump phraseology. I love that there is no mention of the payers in there! Who is going to cover this drug? Seeing how none of the other bariatric drugs have favorable coverage it is unlikely that this one will. No need for this model as we have two recent real world models not prospective models with Xenical and Meridia. Nice that they failed to mention that of the 7% of accessible patients probably only 1-2% will have with insurance or cash that will pay for the drug.

 

[Anonymous]

Look at Janet Woodcock's comments about obesity drugs this week. It's toast or delayed at least 2 - 3 years.

Exactly. The risk/reward ratio has to improve in order for these mess to be considered viable options once again. Also, you've got to love Arena's announcement that they are not going to complete the 12-month safety study, as requested by the FDA, on order to figure out how this drug caused cancerous tumors in rats. Instead, they are going to conduct a 90-day safety trial. Let me guess, the FDA will tell them it wasn't long enough?

 

[Anonymous]

Stock pump phraseology. I love that there is no mention of the payers in there! Who is going to cover this drug? Seeing how none of the other bariatric drugs have favorable coverage it is unlikely that this one will. No need for this model as we have two recent real world models not prospective models with Xenical and Meridia. Nice that they failed to mention that of the 7% of accessible patients probably only 1-2% will have with insurance or cash that will pay for the drug.

Yeah .. You're right of course. OHhhh- wait a minute. Managed Healthcare companies would much rather pay the billions of dollars they pay out annually to treat chronic Diabetes II, and preventable Cardiovascular episodes from Americans being obese. Yeah -- you're right, they are not at all interested in saving those billions and improving their long term investment in a less fat America.
-As far as our economy and Americans paying out of pocket... DUH.. Have you seen the profits of Jenny Craig, weight watchers, Nutrisystem... etc, etc, etc. Billions.

Get a grip and get educated --sh-T even Michelle Obama knows more than you. That's not a good thing by the way.

 

[Anonymous]

Exactly. The risk/reward ratio has to improve in order for these mess to be considered viable options once again. Also, you've got to love Arena's announcement that they are not going to complete the 12-month safety study, as requested by the FDA, on order to figure out how this drug caused cancerous tumors in rats. Instead, they are going to conduct a 90-day safety trial. Let me guess, the FDA will tell them it wasn't long enough?

You really are a complete f-ing idiot. Do you have any clue as to why they call toxicology studies- toxicology studies? Do you have any idea how many drugs on the market now caused some sort of tumor in the toxicology/animal studies prior to the human dose ranging studies? Do YOU ? You need to shut the F-ck up and stop showing your ignorance. Oh... by the way, just to help you along.... Do you have any idea how many humans in the course of over 15000 people treated with Lorcaserin..over both short and long term have developed any tumors from the drug? Yeahhhh.... Ya might want to look this up. Ya Jack off

 

[Anonymous]

You really are a complete f-ing idiot. Do you have any clue as to why they call toxicology studies- toxicology studies? Do you have any idea how many drugs on the market now caused some sort of tumor in the toxicology/animal studies prior to the human dose ranging studies? Do YOU ? You need to shut the F-ck up and stop showing your ignorance. Oh... by the way, just to help you along.... Do you have any idea how many humans in the course of over 15000 people treated with Lorcaserin..over both short and long term have developed any tumors from the drug? Yeahhhh.... Ya might want to look this up. Ya Jack off

Not the person you replied to in this post, but toxicology is not going to be this issue per se. It is going to be a payer issue, and a perception issue. Again the model on fierce pharma is grossly inaccurate since a real time model with Xenical are available. Payers will not pick this drug up and people will not pay out of pocket it for it unless they are well off. The heyday was the fen-Phen clinics and there will be nowhere near that market potential with any new weight loss drug. I wouldn’t worry about tox/efficacy I would worry about who is going to pay for it and what doctors are going to be comfortable jumping in to the bariatric treatment world again after they got burned pretty badly last go around. Many physicians including IM, FP, OGBYN, GI, etc, opened ‘weight loss’ centers only to lose their asses when the bottom fell out. Malpractice insurance premiums alone after the pondimin redux debacle become a huge obstacle to entry into the weight loss world. Unless this drug gets reimbursed by private insurance, which again is highly unlikely, the run of the mill FP or IM is not going to be interested in prescribing this drug. Unless this drug gets major health plan coverage it will be DOA, and I hope you understand that the history of payers paying for weight loss drugs does not bode well for Lorcaserin, and that is what the fierce pharma model failed to recognize.

 

[Anonymous]

A good rule of thumb is to run from anything Eisai touches at about 1 million miles per hour.

 

[Anonymous]

Yeah .. You're right of course. OHhhh- wait a minute. Managed Healthcare companies would much rather pay the billions of dollars they pay out annually to treat chronic Diabetes II, and preventable Cardiovascular episodes from Americans being obese. Yeah -- you're right, they are not at all interested in saving those billions and improving their long term investment in a less fat America.
-As far as our economy and Americans paying out of pocket... DUH.. Have you seen the profits of Jenny Craig, weight watchers, Nutrisystem... etc, etc, etc. Billions.

Get a grip and get educated --sh-T even Michelle Obama knows more than you. That's not a good thing by the way.

First stop being a wise ass as you clearly have no idea what you are talking about past the company kool-aid and a sale rep perspective. Listen to the adult professionals for a minute as I am not a sample bot, I’ve worked in managed markets for 18 years with the nation’s largest payers. Comparing weightless programs to pharmaceutical weightless drugs is grossly inaccurate. In case you haven’t noticed people flock to non-pharmaceutical remedies for a variety maladies like obesity, hence why the nutraceutical/weight loss program industry is so profitable. Nutraceuticals and weight loss programs, etc seem “safer” to the vast majority of the public than a ‘pharmaceutical’, especially after the fen-Phen/Redux issues, so again you are inaccurate in your assumption to use non pharmaceuticals as your litmus to what people are willing to pay for out of pocket to lose weight. If that were the case Xenical would be a blockbuster. To your misguided point, payers will continue to pay for all the comorbidities associated with obesity versus an anti-obesity drug, as insulin is cheap, and heart meds are cheap. I hear what you are saying but your logic is flawed, and that is why payers will not change the way they look at this. In their eyes, and rightfully so, even the most successful weight loss interventions be it, pharmaceutical, behavioral, nutritional, exercise, etc, have very high failure and relapse rates. Failure is the norm and very few people have sustained health changing results from any weight loss intervention. Most people fail, plain and simple. Those who have sustained success make life changing nutritional, exercise, and behavioral choices, and not from pharmaceutical intervention. The payers know this and there are dozens of cost of disease models out there for obesity. Their perspective has been, yes we could pay for a pharmaceutical weight loss drug that costs $60 a month, but we know that 95%+ of those people even if they lose weight, have a high propensity of rebounding back to obesity within 12 months, thus we will still be paying for all the medications and treatments associated with the comorbidity of obesity. Why add the X many months of the weight loss drug and the frequent visits to the physician to the tab if the outcome is going to be the same? If payers were so concerned about weight loss they would more readily and robustly cover programs like Jenny Craig, Weight watchers, dieticians, nutritionists, bariatric behaviorists/psychologists, etc. Fact is that most payers do not cover or cover at a very low level those types of interventions and almost none cover bariatric pharmaceuticals as there are no long term studies that prove pharmaceutical intervention works in terms of lowering comorbidities or that it lowers the cost associated with caring for the obese over the long term. Look at fen-Phen. The average patient was on fen-phen for three months, they lost substantial weight, an almost all gained back every pound plus 5-10% more within a year. Again payers have this data. BTW insulin and most heart meds are generic and cheap and really only require two to three office visits a year. Weight loss…those patients will be in the office weekly for a few months. It may not be a level one visit reimbursement wise but there will be a cost associated to it that payers will have to pay to clinicians.


I live in the payer/reimbursement world everyday junior, next time do your research on reimbursement before you come on here spouting your nonsense.

 

[Anonymous]

..."Again payers have this data. BTW insulin and most heart meds are generic and cheap and really only require two to three office visits a year. Weight loss…those patients will be in the office weekly for a few months. It may not be a level one visit reimbursement wise but there will be a cost associated to it that payers will have to pay to clinicians. "

Yeah -- Your a Big Pharma Reimbursement guru... Goodie two-shoes. Looking at this - You're a dumb ass any way you cut it! Think about what you say here... Your WRONG

 

[Anonymous]

..."Again payers have this data. BTW insulin and most heart meds are generic and cheap and really only require two to three office visits a year. Weight loss…those patients will be in the office weekly for a few months. It may not be a level one visit reimbursement wise but there will be a cost associated to it that payers will have to pay to clinicians. "

Yeah -- Your a Big Pharma Reimbursement guru... Goodie two-shoes. Looking at this - You're a dumb ass any way you cut it! Think about what you say here... Your WRONG

Yup you work for Eisai alright! When someone gives you facts you don’t respond in kind with facts you just say, ‘you’re wrong’ with not substantiation of why or a thoughtful rebuttal.

 

[Anonymous]

First stop being a wise ass as you clearly have no idea what you are talking about past the company kool-aid and a sale rep perspective. Listen to the adult professionals for a minute as I am not a sample bot, I’ve worked in managed markets for 18 years with the nation’s largest payers. Comparing weightless programs to pharmaceutical weightless drugs is grossly inaccurate. In case you haven’t noticed people flock to non-pharmaceutical remedies for a variety maladies like obesity, hence why the nutraceutical/weight loss program industry is so profitable. Nutraceuticals and weight loss programs, etc seem “safer” to the vast majority of the public than a ‘pharmaceutical’, especially after the fen-Phen/Redux issues, so again you are inaccurate in your assumption to use non pharmaceuticals as your litmus to what people are willing to pay for out of pocket to lose weight. If that were the case Xenical would be a blockbuster. To your misguided point, payers will continue to pay for all the comorbidities associated with obesity versus an anti-obesity drug, as insulin is cheap, and heart meds are cheap. I hear what you are saying but your logic is flawed, and that is why payers will not change the way they look at this. In their eyes, and rightfully so, even the most successful weight loss interventions be it, pharmaceutical, behavioral, nutritional, exercise, etc, have very high failure and relapse rates. Failure is the norm and very few people have sustained health changing results from any weight loss intervention. Most people fail, plain and simple. Those who have sustained success make life changing nutritional, exercise, and behavioral choices, and not from pharmaceutical intervention. The payers know this and there are dozens of cost of disease models out there for obesity. Their perspective has been, yes we could pay for a pharmaceutical weight loss drug that costs $60 a month, but we know that 95%+ of those people even if they lose weight, have a high propensity of rebounding back to obesity within 12 months, thus we will still be paying for all the medications and treatments associated with the comorbidity of obesity. Why add the X many months of the weight loss drug and the frequent visits to the physician to the tab if the outcome is going to be the same? If payers were so concerned about weight loss they would more readily and robustly cover programs like Jenny Craig, Weight watchers, dieticians, nutritionists, bariatric behaviorists/psychologists, etc. Fact is that most payers do not cover or cover at a very low level those types of interventions and almost none cover bariatric pharmaceuticals as there are no long term studies that prove pharmaceutical intervention works in terms of lowering comorbidities or that it lowers the cost associated with caring for the obese over the long term. Look at fen-Phen. The average patient was on fen-phen for three months, they lost substantial weight, an almost all gained back every pound plus 5-10% more within a year. Again payers have this data. BTW insulin and most heart meds are generic and cheap and really only require two to three office visits a year. Weight loss…those patients will be in the office weekly for a few months. It may not be a level one visit reimbursement wise but there will be a cost associated to it that payers will have to pay to clinicians.


I live in the payer/reimbursement world everyday junior, next time do your research on reimbursement before you come on here spouting your nonsense.

Whippppeee Mr 15 yrs in Reimbursement. Because you are sooooo smart and understand the market pulse so intricately - you probably didn't overlook the oppportunity to buy this stock at 1.6 and sell over 3.00 just to cover and reinvest after earning a cool 10K. Oh--- what's that? You thought you had your feeble mind wrapped around this market --- Oh , what's that? the sounds of you sobbing --- sorry Jack-off -- Should have used those 15 years of in-depth experience to learn from those more mature and senior to you in this industry. Just saying!
ps - the good part is... there's still time. This stock will double again before 5/10! write that down Junior.. I'll say it again more slowly ... ARNA Will Double Again Before 5/10 COM.

I think I'll take a vacation now!!

 

[Anonymous]

Please stop the beat down on our poor Reimbursement-MCO guy. He clearly means well, just gets a bit over the top with himself sometime. I too have purchased a crap-load of Arena's stock and should consider a vacation. I certainly don't have to worry about my worthless bonus here.

 

[Anonymous]

For Those interested in future of Lorcaserin and either spreading or questioning myths of CV implications of this drug as they relate to ultimate approval of Lorcaserin:
Read...or remain ignorant - your call:

"Arena performed large scale phase 3 studies of over 8000 patients of which there were no CV events in the lorcaserin study population. The FDA did not have single concern with MACE/CV events with regard to lorcaserin and this demonstrably evident in the content of the CRL. The Adcomm meeting should be, if the FDA follows it own protocols and procedures, discuss what was required of Arena in the CRL. They cannot impose a pre approval study on Arena regarding CV events for two reasons: there were no CV events in any of the 3 phase 3 trials, and second, you cannot request a MACE/CVOT study without having guidance in place. The Adcomm meeting’s purpose is to address the CRL issues and determine whether or not Arena answered all the concerns conclusively. LET US NOT FORGET THIS. If you look at the CRL the primary concern, admittedly unjustified, is, ‘Is there a mammary cancer and an astrocytoma cancer risk associated with the use of lorcaserin and is this risk translated to human risk.’

ps- This tumor ? is a non-issue. Facts are - in 2010, the FDA didn't have one tumor specialist on the approval board - and the raising of this non-issue was more of a political move than a clinical question as VVUS & Orexigen's drugs had both already failed approval and they (FDA-not a non-biased entity) wanted to maintain level field...